FDA Warning

[Guest guest]

Hi everyone!

I just want to be sure you're aware of this. Even if you don't take

it, you might know someone who does.

Hugs,

Deanna Tubb

New Mexico PAI Rep

April, 28 2004 -- The FDA today issued a warning associated with the

irritable bowel syndrome (IBS) drug Zelnorm.

The FDA says Zelnorm has been associated with serious cases of

diarrhea as well as instances of ischemic colitis -- a medical

condition where blood flow is reduced to the intestines.

Zelnorm is a prescription medication for the short-term treatment of

women with IBS whose primary bowel symptom is constipation. The FDA

says it's adding this new drug information to ensure doctors and

patients have the most current and complete information available

when prescribing and taking Zelnorm.

The specific revisions include:

A new warning about the serious consequences of diarrhea associated

with the medication

A new precaution about ischemic colitis and other forms of reduced

blood flow to the intestines

Changes to side effects information section describing information

gathered since the drug was approved in July 2002

The New Warning

In the new warning, the FDA states that serious consequences of

diarrhea, including significant loss of fluid, low blood pressure,

and episodes of passing out, have been reported in the clinical

studies and during marketed use of Zelnorm. In some cases, these

complications have required hospitalization for rehydration.

The FDA recommends that Zelnorm be discontinued immediately in

patients who develop low blood pressure or passing out spells.

Zelnorm should not be used in patients who are currently experiencing

or frequently experience diarrhea.

The New Precaution

The FDA has also issued a precaution regarding the risk of reduced

blood flow to the intestines, which may lead to inflammation of the

intestines, called ischemic colitis.

In the new precaution, the FDA states that ischemic colitis and

other, similar conditions have been reported in patients taking

Zelnorm. Although this association has been observed, the FDA says

that Zelnorm has not been proven to cause this effect. The FDA adds

that clinical trials comparing Zelnorm to placebo in 7,000 patients

for three months showed no cases of these events. This suggests the

rate of such events is low, according to the FDA.

The agency says Zelnorm should be discontinued immediately in

patients who develop symptoms of ischemic colitis, such as rectal

bleeding, bloody diarrhea, or new or worsening abdominal pain.

Treatment with Zelnorm should not be resumed in patients who develop

findings consistent with ischemic colitis.

The FDA advises patients who get new or increased stomach pain or

blood in their stools to stop taking Zelnorm right away and to

immediately contact their doctor to determine if they may have a

serious problem. In addition, the FDA advises patients to stop taking

Zelnorm and to call a doctor right away if they experience diarrhea

that leads to lightheadedness, dizziness, or fainting.

Zelnorm is the only FDA-approved prescription drug for the short-term

treatment of women with irritable bowel syndrome whose primary bowel

symptom is constipation.

Zelnorm increases the movement of stools through the bowels. Zelnorm

does not cure IBS, nor does it treat the type of IBS where diarrhea

is the predominant symptom. Zelnorm reduces pain and discomfort in

the abdominal area and reduces bloating and constipation. The safety

and effectiveness of Zelnorm in men have not been established.